A Global Learning Agenda for the Levonorgestrel Intrauterine System (LNG IUS): Addressing Challenges and Opportunities to Increase Access

The LNG IUS is also associated with a number of important noncontraceptive health benefits, including treatment for menorrhagia (heavy menstrual bleeding) and uterine fibroids, and potentially for anemia. The localized release of hormones and relatively low systemic blood levels compared with other hormonal methods may result in less pronounced side effects. The LNG IUS has been a popular choice with women in developed countries where the method is available, and it has helped revitalize the IUD market in some settings. In the United States, the 5-year LNG IUS product, Mirena, was first introduced in 2000, and by 2014, 74% of women with an IUD were using a hormonal product. However, the method is not currently available at scale outside of the commercial sector in any of the Family Planning 2020 (FP2020) focus countries, and thus access to the larger population for this method is limited in these settings. Historically, the high cost of LNG IUS commodities has been a primary barrier to public-sector procurement in international settings, and therefore to inclusion in the contraceptive method mix in national family planning programs. Recent market assessments conducted in Kenya, Madagascar, Nigeria, and Zambia have documented prices of Mirena to clients in urban settings ranging from US$60 to $400. An unbranded LNG IUS product manufactured by Bayer Healthcare is available for free through donations made by the International Contraceptive Access (ICA) Foundation, a private-public partnership between Bayer Healthcare and the Population Council. New LNG IUS products are starting to become available in some FP2020 markets, including a new product distributed by Medicines360, a non-profit pharmaceutical company, which was approved by the U.S. Food and Drug Administration in 2015 and is currently being registered in FP2020 countries under the trade name Avibela. The international public-sector procurement price for Avibela will vary by volume between US$12 to $16 per unit, with a public-sector price of approximately US$15 per unit for an order of 100,000 units. This price is comparable to other contraceptive methods commonly procured in FP2020 countries, and emerging evidence suggests that the duration of effectiveness of the LNG IUS is at least 7 years, which would further reduce the cost per couple-years of protection (CYP). Despite the potential cost-effectiveness of the LNG IUS, high upfront commodity costs can still be a barrier to procurement by donors and governments. Similar to the LNG IUS, contraceptive implants were not scaled up in low- and middle-income countries (LMICs) for many years, partly because of high commodity costs. However, since the introduction of a more affordable 2-rod implant, Sino-implant (II)/Levoplant, and after the launch of the Implants Access Program, implant use has grown rapidly in a number of FP2020 countries. The more affordable pricing for implants has set a new bar, which could impact expectations for pricing of the LNG IUS.